Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
C.R. Bard Inc is recalling the BD InLay Optima Ureteral Stent Kit (6 Fr. x 30 cm) due to a labeling discrepancy where the actual device size may not match the product label.
Steris is recalling 22 AMSCO 7053HP Washer/Disinfectors because a wire may shift and cause internal electrical arcing. While the arcing poses no electric shock risk, healthcare facilities should verify if they have affected units.
C.R. Bard is recalling 116 units of Bard InLay Optima Size 6 Fr. x 14 cm Ureteral Stent Kits because the actual stent size may not match the product label.
Medline is recalling CURAD Germ-Shield Touch-Free Fabric Bandages because packaging seals may be open, potentially compromising product sterility. Consumers should stop using affected units.
The Safe-T-Centesis 6 Fr Catheter Drainage Tray has a faulty safety indicator that may show the catheter is in the wrong position, potentially causing treatment delays or internal organ injury.
Stryker is voluntarily recalling 297 Arise 1000EX mattresses sold near MV3 beds because these products were not tested for compatibility and are not designed to be used together.
Medline is recalling Curad Quick Strip Fabric Bandages (18,000 units) due to open seals that may compromise sterility. Distribution affected: US, Guam, Canada, and United Arab Emirates.
Stryker has issued a voluntary recall of 294 MV3 bariatric beds because these units were sold in proximity to Arise 1000EX mattresses that have not been tested for compatibility and are not designed to be used together.
Medline's DEXLOCK Achilles Repair Implant Kits may experience drill bit fusion to the drill guide bushing during surgery, potentially prolonging procedures. 163 units were distributed nationwide.
Medline Industries recalled Perfusion Syringes containing BD Luer Tip Caps that failed biocompatibility testing. The caps may cause sensitization, irritation, pyrogenicity, or acute systemic toxicity, though no patient injuries have been reported.
Medline is recalling all lots of Quick Strip Plastic Sterile Adhesive Bandages (1" x 3") due to open seals in packaging that may compromise sterility. No injuries have been reported.
BD InLay Optima Ureteral Stent Kit (Lot# NGJU4328) recalled due to labeling discrepancy where actual stent size may not match product label. Approximately 116 units distributed worldwide.
C.R. Bard is recalling BD InLay Optima Ureteral Stent Kits (4.7 Fr x 26 cm) due to a labeling discrepancy where actual stent size may not match the product label. Lot NGJU4181 with approximately 4,350 units affected worldwide.
Nipro Medical Corporation is recalling Hemodialysis System Surdial DX units due to a screw that may loosen or fall out. Affected systems were distributed nationwide. Patients should contact their healthcare provider immediately.
A knee fusion nail component was distributed with a locking screw incorrectly inserted from the wrong side into the taper. This manufacturing defect could compromise proper implant fixation and stability.
Medline is recalling approximately 1.7 million Quick Strip Plastic Sterile Adhesive Bandages due to open packaging seals that may compromise product sterility. Affected products were distributed in the US, Guam, Canada, and UAE.
Medline Industries is recalling Curad Touch-Free and Quick-Strip Sterile Adhesive Bandages due to potential open package seals that could compromise product sterility. Approximately 1.57 million units were distributed in the US, Guam, Canada, and UAE.
Philips recalled 110 Azurion 7 M20 fluoroscopic X-ray systems in the U.S. shipped without a required Source-to-Skin Distance Spacer. The missing component may prevent systems from meeting FDA radiation safety distance requirements.
Datascope Corp. is updating the preventative maintenance schedule for the Cardiosave Rescue Intra-Aortic Balloon Pump system in an FDA Class II recall. The Instructions for Use addendum aligns maintenance procedures with updates to the Service Manual from June 2023.
Orthofix U.S. LLC is recalling 61,977 CONSTRUX Mini PTC Spacer System units due to labeling that contains claims not consistently present. No injuries or illnesses have been reported.
Orthofix U.S. LLC is recalling the Pillar SA PTC Spacer System due to product labeling containing claims that are not consistently present. Approximately 13,317 units were distributed worldwide.
Steris Corporation recalls AMSCO 7052HP Washer/Disinfectors because a wire in the electrical box may shift and cause internal electrical arcing. No shock risk is posed to users.
The Cardiosave Hybrid intra-aortic balloon pump maintenance schedule is being updated. Datascope Corp. revised preventative maintenance procedures to align with June 2023 service manual updates.
Orthofix U.S. LLC is recalling CONSTRUX Mini Ti Spacer System due to labeling inconsistencies where claims are not consistently present on affected devices.
Beckman Coulter is recalling 38,225 Access 2 Reaction Vessels that may have manufacturing deformities causing instrument errors and delays in patient test results.
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